Feasibility Study of Fiducial Markers in Oesophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02403050
• Other study ID #: GN14ON144
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 25, 2015
• Start date: March 2015
• Est. completion date: March 2019

Study information

• Verified date: March 2015
• Source: NHS Greater Glasgow and Clyde
• Contact: Vivienne MacLaren, MBChB, FRCP
• Phone: 441413017093
• Email: v.maclaren[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy, a Computerised tomography (CT) scan is performed and is the dataset used for planning radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised on CT. This information is subjective and dependant on the clinician performing the procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of this information can lead to over-compensation when attempting to cover the tumor with a radiation field, to avoid a "miss". It is thought that using fiducial markers called Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will lead to better definition of the tumor in the planning process and hence, improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• esophageal adenocarcinoma or squamous carcinoma, or undifferentiated carcinoma.

• No previous radiotherapy or chemotherapy.

• Fit for radical treatment of their cancer with reasonable lung function, Fev1 >40%, and EUS planned.

• ECOG Performance Status 0-1: 0 - Fully active, able to carry on all predisease performance without restriction 1 - Restricted in physically strenuous activity

Exclusion Criteria:

• Pregnancy or breast feeding.

• Allergy to ciprofloxacin antibiotics

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Device:
• Fiducial markers
2 fiducial markers (Visicoils) to be placed in the tumor area

Locations

Country	Name	City	State
United Kingdom	Beatson Oncology Centre	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation	Comparison of intra- and inter-observer variability in estimation of tumor target volume (mean and standard deviation) in the prospective (fiducial markers) and retrospective (no fiducial markers) cohorts. Data will be reported using planning volumes measured in cubic centimetres.	baseline (pre-radiotherapy)	Yes
Secondary	Patient survival		6 months post radiotherapy	No
Secondary	local recurrence of tumor	radiological or clinical evidence of disease recurrence	6 months post radiotherapy	No
Secondary	Patient survival		12 months post radiotherapy	No
Secondary	local recurrence of tumor	radiological or clinical evidence of disease recurrence	12 months post radiotherapy	No
Secondary	Patient survival		18 months post radiotherapy	No
Secondary	local recurrence of tumor	radiological or clinical evidence of disease recurrence	18 months post radiotherapy	No
Secondary	Patient survival		2 years post radiotherapy	No
Secondary	local recurrence of tumor	radiological or clinical evidence of disease recurrence	2 years post radiotherapy	No